Kornimate/medical-research-clean huggingface dataset:
psychosomatic factors influencing the efficacy of holistic care for migraine

Conditions: Migraine

Summary: this research project aims at exploring the psychosomatic factors that influence and moderate the efficacy of holistic care and personalized treatment for migraine patients. it is a prospective longitudinal observational study. the project's goal is to understand how physical, psychological, spiritual, and social factors affect the care and treatment outcomes for migraineurs. the study will include participants aged 18 to 65, who meet the international headache society's criteria for migraines. it will utilize a range of methodologies including questionnaires, interviews, and medical records to collect data on various factors like lifestyle, psychological state, and social support. the project will assess the effectiveness of treatments, compliance, and other outcomes such as emotional and sleep conditions.

in this study, participants will be recruited through clinics. all the participants will be asked to keep a migraine diary for the duration of three months. in addition to that, the participants will fill out questionnaires that measures depression, anxiety, well-being and migraine related disability. this study does not intervene with the routine clinical care. the investigators merely observe through participant's diary and other patient reports to find out about how psychological and social factors might lead to different clinical outcomes.

Eligibility criteria:
inclusion criteria: * individuals aged between 18 and 65 who meet the international headache society's criteria for migraines exclusion criteria: * incapacitate such as dementia or cognitive deficiency * illiterate, or could not sign informed consents * severe disorder or co-morbidities that the doctors advice against participation

Keywords: migraine holistic care personalized treatment
evaluation of the effect of sglt-2 inhibitors on atrial fibrillation recurrence in diabetic patients

Conditions: Diabetes Mellitus; Atrial Fibrillation (AF)

Summary: consecutive dccv was performed until to achieve 120 patients in sr (60 dm patients who used sglt-2 inhibitors and 60 dm patients who did not use sglt-2 inhibitors). patients defined as sglt-2 inhibitor user group and control group. the two groups were monitored for af recurrence on the first day, then at one, three, and six months after cv.


Eligibility criteria:
inclusion criteria: * patients \> 18 years and \< 90 years, * patient diagnosed with dm * patient underwent electrical cardioversion due to af and was restored to sinus rhythm exclusion criteria: * patient who are not suitable for anticoagulant use, * have thyroid dysfunction, * glomerular filtration rate ≤ 25 ml/min/1.73 m², * patients whose sinus rhythm cannot be achieved with electrical cardioversion, * malignancy patients, * patients with acute or chronic inflammatory disease, * patients with peripheral artery disease, * patients with pacemakers, * patients with advanced valve stenosis or insufficiency, * patients who have had coronary bypass surgery, * patients with percutaneous or surgical bioprosthesis or metallic valve surgery.
transbronchial needle aspiration in the diagnosis of peripheral pulmonary malignancy

Conditions: Pulmonary Nodule; Pulmonary Mass

Summary: the main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (tbna) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.

in a recent systematic literature review (rivera pm, mehta ac; chest 2007; 132: 1318-1488) tbna showed the highest sensitivity in the diagnostic bronchoscopic approach to peripheral pulmonary lesions, as compared to the other available sampling techniques (transbronchial biopsy, brushing, washings). however, the authors conclude that the data regarding tbna in this setting deserve cautious interpretation because of the limited number of studies and the large differences in sample size). we designed the present study to assess the performance characteristics of tbna, alone and in comparison with those of transbronchial biopsy, in the diagnosis of peripheral pulmonary lesions.

Eligibility criteria:
inclusion criteria: * age 18 years and older * pulmonary nodule (\ 3 cm) at computed tomography exclusion criteria: * refusal to sign informed consent * uncontrolled coagulopathy * pregnancy

Keywords: lung cancer lung nodule transbronchial needle aspiration transbronchial lung biopsy bronchoscopy
comparison of rotational angiography/electroanatomical mapping fusion versus ct/electroanatomical mapping fusion to guide af ablation

Conditions: Atrial Fibrillation; Arrhythmia

Summary: the purpose of this study is to compare rotational angiography (3datg technology)intra-procedure (during the ablation procedure) with ct (x-ray) pre-procedure (before the ablation procedure) fusion to create an anatomical picture of a heart to help adequately guide an ablation procedure for patients with arrhythmias.

rotational angiography (or three dimensional arteriography or "3datg") is a new tool used to guide atrial fibrillation (af) ablation. the current approach to imaging for af ablation involves obtaining a computer tomography (ct) angiogram of the atrium pre-procedure and combining it with an electro-anatomical map, a process called merging or overlay. the investigators propose to investigate the quality of the 3datg as a replacement for the ct in obtaining a left atrial angiogram (to guide af ablation). all imaging modalities to be evaluated in this study are currently used in clinical practice. they are not experimental methods. the goal is to compare two modalities that have never been directly compared before. the ct angiography utilizes a standard ct scanner and intravenously injected contrast agent to visualize the left atrium. while the 3datg is a method that achieves similar results to a ct scanner, the difference is that the 3datg images are acquired by rotating the x-ray source around the patient on a c-arm instead of a dedicated ct scanner. 60 participants will be consented and randomized to either pre-procedure ct or intra-procedure 3datg. scheduled participants will undergo sedation and catheter instrumentation as appropriate. ct anatomy data will then be merged with the live x-ray via the ep navigator system in standard fashion or the patient will be prepped for appropriate 3datg anatomy data acquisition and merged with the ep navigator system. the ep navigator system will then be used to send either data to navx or carto to create the intended electro-anatomical map. using the ct or 3datg acquired electro-anatomical map, the ablation procedure will be conducted in the same way as would the local practice and standard of care for any patient not participating in the study. the ablation procedure and the sites of ablation lesions will be tagged on the 3d overlaid anatomy in the same fashion as previously published and all participants will be followed as routine at a 1 month and 3 month follow up.

Eligibility criteria:
inclusion criteria: * all patients undergoing a clinically indicated left-sided ablation procedure for atrial fibrillation exclusion criteria: * patients not willing or able to provide consent to participate or already involved in another clinical trial.

Keywords: atrial fibrillation catheter-based ablation pulmonary vein isolation electro-anatomical mapping rotational angiography
just-in-time adaptive interventions for diabetic patients

Conditions: Diabetes; Self-Control; Telemedicine

Summary: the addition of proactive nurse consultations was useful to older adults with diabetes mellitus in facilitating their chronic disease self-management. however, the service is time and resource-intensive. with the support of advanced technology, mhealth app seems to be a convenient way to support patients in managing diabetes.

this study examines the effectiveness of mhealth app plus nurse consultations in promoting self-management behaviours for diabetic patients.

Eligibility criteria:
inclusion criteria: * with a confirmed dm diagnosis for one year or more than one year * using governmental mhealth app * living in an area with internet coverage exclusion criteria: * already engaged in other mhealth programmes * physical and cognitive limitations

Keywords: telecare older adults diabetes
treatment of acute sinusitis with high-dose vs. standard-dose amoxicillin/clavulanate

Conditions: Sinusitis, Acute

Summary: comparative-effectiveness study of the treatment of acute bacterial sinusitis with amoxicillin/clavulanate 875mg/125mg bid for 7 days with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. .

double-blind comparative-effectiveness study of the treatment of acute bacterial sinusitis with standard dose of amoxicillin/clavulanate 875mg/125mg bid for 7 days, as recommended by the infectious disease society of america, with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. the study aims are 1) to confirm, or not, our recent findings of more rapid improvement in overall symptoms with the additional amoxicillin, but also of more frequent diarrhea and vaginal yeast infections and 2) to assess, from the participants' point of view, the balance between improvement and adverse effects.

Eligibility criteria:
inclusion criteria: 1. adults 18 and older who are patients at the albany medical center internal medicine and pediatrics practice (study site). 2. clinical diagnosis of acute bacterial sinusitis in accordance with the guidelines of the infectious disease society of america (fitting into one of 3 categories: persistent sinus symptoms for 10 days or more; severe sinus symptoms for 3 days or more; or worsening sinus symptoms after initial improvement (double sickening). exclusion criteria: 1. previous enrollment in the current study 2. allergy or intolerance to any penicillin or to amoxicillin/clavulanate 3. serious hypersensitivity reaction to any beta lactam 4. elevated risk of amoxicillin-resistant bacteria: a. amoxicillin, penicillin, or other beta-lactam within the past month; b. known to have had methicillin-resistant staph aureus 5. chronic or recurrent "sinus" problems (defined as a) persistent symptoms of "sinus" congestion, not attributed to nasal allergies, for 8 weeks or more or b) 2 or more episodes of antibiotic-treated "sinusitis" in past 3 months 6. need to use high-dose amoxicillin/clavulanate or levofloxacin or to send to emergency department or to hospitalize because of a) signs of severe infection or b) immunocompromise 7. cognitive impairment, so unable to give reliable symptom ratings (even if a health proxy can give consent) 8. pregnant women and nursing mothers 9. drug warnings: a) taking allopurinol; b) current mononucleosis; c) chronic kidney disease stage 4 (estimated glomerular filtration rate \<30); d) hepatic impairment (not including isolated transaminase elevated \< 2 times upper limit of normal); e) history of antibiotic-associated colitis (c. difficile)
optimizing antidepressant treatment by genotype-dependent adjustment of medication according to the abcb1 gene

Conditions: Major Depression

Summary: the study evaluates the abcb1-genotype dependent efficacy of a quick dose-escalation strategy within 28 days of treatment with approved antidepressants that are known substrates of the p-glycoprotein, an efflux pump of the blood-brain barrier expressed by the abcb1 gene. moreover, the study evaluates abcb1-genotype dependent side-effects of approved antidepressants that are known substrates of the p-glycoprotein, an efflux pump of the blood-brain barrier expressed by the abcb1 gene.


Eligibility criteria:
inclusion criteria: * male and female patients * age between 18 and 80 years * inpatients with a dsm-iv diagnosis of major depression * single episode or recurrent * moderate to severe intensity * without psychotic features * inpatients with a dsm-iv diagnosis of bipolar disorder i or ii * current episode with depressive symptoms * moderate to severe intensity * without psychotic features * ham-d score at the time of inclusion in the study ≥ 14 * patient has already been adjusted to one of the following antidepressants in a dose which is still under the defined normal-dose: * paroxetine \< 40 mg/d * sertraline \< 100 mg/d * citalopram \< 40 mg/d * escitalopram \< 20 mg/d * venlafaxine \< 225 mg/d * amitriptyline \< 150 mg/d * amitriptylinoxide \< 150 mg/d * nortriptyline \< 150 mg/d * trimipramine \< 150 mg/d exclusion criteria: * acute suicidality (ham-d item 3 score \> 2) * acute alcohol-, hypnotics-, analgesics- or psychopharmacological intoxication or delirium * current alcohol dependence, or dependencies from other psychotropic substances * severe medical or neurological diseases: patients with severe hepatic (severe impairment of liver function, cirrhosis of the liver), renal (kidney malfunctions), cardiovascular (recent myocardial infarction, instable heart disease), neurological diseases (e.g. multiple sclerosis, parkinson, dementia) * patients incapable of giving informed consent * pregnant or breast-feeding women * women of reproductive age without effective contraception * simultaneous participation in other clinical trials or participation in an other clinical trial within 6 weeks before the start of the study * hypersensitivity to the study medication or to one of the ingredients of the medication * simultaneous treatment with another antidepressant besides study medication (exception: trazodone up to 75 mg/d, mirtazapine up to 15 mg/d, trimipramine up to 50 mg/d) * simultaneous treatment with mood stabilizers or neuroleptic drugs (exception: quetiapine up to 50 mg/d, olanzapine up to 5 mg/d) * exclusion criteria of the study medication

Keywords: depression, affective disorder
sleep apnea and oxidative stress and nitric oxide

Conditions: Sleep Apnea Syndromes

Summary: background: previous studies present contradictory data concerning obstructive sleep apnea syndrome (osas), lipid oxidation and nitric oxide (no) bioavailability. this study was aimed: (1) to compare the concentration of 8-isoprostane and total nitrate and nitrite (nox) in plasma of middle aged males with osas and no other known comorbidity and carefully matched healthy controls of the same age and gender; and (2) to test the hypothesis that nasal continuous positive airway pressure (cpap) therapy, might attenuate oxidative stress and nitrate deficiency.

we performed a single-center, prospective, randomized, double-blind, placebo-controlled and cross-over clinical study, in which patients received cpap and sham therapy for two 12-week periods. baseline measurements in healthy controls matched for age and gender were also obtained. at recruitment, 24-h blood pressure monitoring (abpm), an echocardiogram (to rule out any cardiac dysfunction) and a sleep study was obtained in all participants . after fasting overnight, a venous blood sample (anti-coagulated with dipotassium edta, for 8-isoprostane and total nitrate and nitrite concentration (nox) determinations) and a urine sample were collected in all of them between 08:00 and 10:00 hours. within 30 minutes of blood collection, plasma was obtained by centrifugation at 3000 rpm for 15 min. all plasma samples were stored at -60°c until analysis. patients with osas underwent a full-night cpap titration study using an automated pressure setting device (auto set; resmed, sydney, australia). compliance with therapy was obtained from a built-in run-time counter. after 12 weeks, cpap device was switched to the alternate mode of therapy and abpm,, plasma and urine sampling were repeated in patients

Eligibility criteria:
inclusion criteria: * apnea-hypopnea index (ahi) ≥10 h-1 * excessive daytime sleepiness defined by an epworth scale score ≥11 points * no treatment for osas. inclusion criteria for healthy control subjects were ahi \<5 h-1 and epworth sleepiness scale \<10. exclusion criteria: * unwillingness or inability to participate in the study * obstructive or restrictive lung disease as identified by pulmonary function testing * use of cardioactive drugs * cardiac rhythm disturbances, including sinus bradycardia and sinus tachycardia * known arterial hypertension, or 24-hour mean blood pressure of 135 and/or 85 mm hg or more * left ventricular ejection fraction \<50%, ischemic or valve heart disease, hypertrophic, restrictive or infiltrative cardiomyopathy, pericardial disease or stroke, by history, physical examination, ecg, chest radiography, conventional exercise stress testing, and echocardiography * diabetes mellitus, by history or 2 random blood glucose levels ≥126 mg/dl * morbid obesity (body mass index \>40 kg/m2) * daytime hypoxemia (pao2 \ 45 mm hg) * need to change medication * hospital admission for 10 or more days * average nightly cpap usage less than 3.5 hours.

Keywords: sleep apnea oxidative stress nitric oxide cardiovascular disease
haplo t-cell depleted transplantation in high-risk sickle cell disease

Conditions: Sickle Cell Disease

Summary: this study is being done to determine the safety and outcome (long-term control) of a high-dose chemotherapy regimen followed by an infusion of cd34 selected (immune cells) stem cells from a partially matched adult family member donor, called haploidentical stem cell transplantation, in high-risk sickle cell disease patients. funding source - fda oopd

the purpose of this study is to investigate host myeloimmunosuppressive conditioning followed by familial haploidentical t cell depleted allogeneic stem cell transplantation in patients with high risk sickle cell disease (scd). it is hypothesized that it will be safe and well tolerated, and result in sustained donor chimerism, acceptable engraftment and immune reconstitution. also, that it will limit scd related organ damage resulting in improved and/or stable neurological, neurocognitive, pulmonary and pulmonary vascular function and health related quality of life (qol). patients 2-20.99 years of age with a diagnosis of high-risk scd and with an unaffected hla partially matched family donor and meeting eligibility criteria (inclusion and exclusion criteria) are eligible.

Eligibility criteria:
inclusion criteria: * homozygous hemoglobin s disease, or hemoglobin s beta0/+ thalassemia * patients must demonstrate one or more of the following sickle cell disease complications 1. clinically significant neurologic event (stroke) or any neurologic deficit lasting \>24 hours that is accompanied by an infarct on cerebral mri 2. minimum of two episodes of acute chest syndrome. 3. recurrent painful events (at least 3 in the 2 years prior to enrollment). 4. abnormal tcd study requiring starting on chronic transfusion therapy. 5. at least one silent infarct lesion on a mri scan of the head. * a familial haploidentical donor without homozygous sickle cell disease * adequate organ function (renal, liver, cardiac and pulmonary function) * karnofsky or lansky (age appropriate) performance score ≥50% * liver biopsy is optional to assess for iron overload in chronically transfused patients. exclusion criteria: * females who are pregnant or breast-feeding * scd patients with documented uncontrolled infection * scd patients who have an unaffected hla matched family donor willing to proceed to donation * karnofsky/lansky (age appropriate) performance score \<50% (hemiplegia alone secondary to a previous stroke is not an exclusion) * demonstrated lack of compliance with medical care. * clinically significant fibrosis or cirrhosis of the liver * previously received a hsct

Keywords: sickle cell disease stem cell transplantation haploidentical
a study to evaluate safety and immune response of novartis meningococcal acwy conjugate vaccine in us adolescents and adults

Conditions: Meningococcal Infections; Meningococcal Meningitis

Summary: this study will evaluate the lot to lot consistency, safety and immune response of the novartis meningococcal acwy conjugate vaccine in healthy us adolescents and adults.


Eligibility criteria:
inclusion criteria: * healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent exclusion criteria: * subjects with a previous or suspected disease caused by n. meningitidis * previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) * previous or suspected disease caused by n. meningitidis * any serious acute, chronic or progressive disease * pregnant or breastfeeding

Keywords: meningococcal meningitis vaccine adolescents adults
retinal surgery with or without anesthesiologist, comparison of surgeon and patient's comfort

Conditions: Retinal Disease

Summary: retinal surgeries are now performed in some hospitals with sub-tenon anesthesia to replace conventional peribulbar anesthesia. the advantages of performing the surgery with tenonian anesthesia can be: the cost reduced due to the non-intervention of an anesthesiologist, no pre-operative anesthetic consultation, no waiting period for the effectiveness of the peribulbar anesthesia (15-20min to have the effect of anesthesia of the eye). in addition, there are more numerous and dangerous complications of peribulbar anesthesia than sub-tenonian anesthesia, however it allows the eye to remain stationary and to perform precise surgery safely, as long as the patient does not move his head. performing a sub-tenonian anesthesia also makes it possible to carry out surgeries more quickly, this method having an immediate effect and being performed by the surgeon, without the intervention of an anesthesiologist. the edema effect under the post / conjunctiva swells the area around the eye and allows partial oculomotor limitation. finally, for the patient, recovery is faster: no sedation or venous route. to date, however, no study has proven that the surgeon can safely operate on the patient without increased complications compared to peribulbar anesthesia. this study aims to show that simple sub-tenonian anesthesia in a short outpatient circuit does not induce more pain or discomfort for the patient than a longer outpatient circuit with bed and anesthesiologist. no studies have been performed on purely local anesthesia without a venous route. for this, patients operated on at the foch hospital without an anesthesiologist under subtenon's anesthesia will be compared to patients operated on under peribulbar anesthesia with an anesthesiologist at the pierre cherest clinic.


Eligibility criteria:
inclusion criteria: * patients over 18 years old * patients with an indication for retinal surgery * not having opposed to participate in the study exclusion criteria: * claustrophobia * unbalanced psychiatric pathology * inability to lie down * deprived of liberty or under guardianship.

Keywords: peribulbar surgery tenonian surgery retinal surgery surgeon comfort patient comfort